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QA Document Controller

Malvern, PA

Posted: 02/18/2021 Industry: R&D Scientist Job Number: JN -022021-12547

Job Description

QA DOCUMENT CONTROLLER

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: QA DOCUMENT CONTROLLER
  • Location: Malvern, PA
  • Industry: Pharmaceutical
  • Hours: 1st shift Mon-Fri 8am - 5pm
  • Salary: $26.00hr (Paid Weekly - Benefits Available)
  • Employment Type: Long Term Contract
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:

The Document Controller coordinates the document control system which includes issuing document numbers, document change management, circulating documents for review and approval, tracking documents at all stages of routing, approval and distribution, maintaining all master documents. Manages batch records.

Essential Functions:
Document Management
Maintaining QA Databases
Review and Approval of controlled documents
Issuing Document/Tracking Numbers
Management of Document Control system and administration of associated training
Issuing and Reconciling ID, CS/PM, Filter bag Forms
Scanning, filing and archiving controlled documents
Document Development/Training
Development, Review, Approval of Relevant Quality System Policies and Procedures
Develop/Provide Training on Quality systems, and Associated Documentation
Development, Review and Approval of Relevant Laboratory Policies and Procedures
Updating training files- review of completed forms and sign off
Batch Manufacturing Record Management
Management of Batch Manufacturing Record Reconciliation
Provide Clients/Regulatory Agencies Copies of Batch Manufacturing Records, as required
Secondary Responsibilities
Review, approval and release of controlled supplies and packaging materials
Review, approval and release of materials for micronization
Mill and Equipment Release
Inspections
Preparing for Client Audits
Performing Internal Audits
Interaction with clients and regulatory agents as needed

Position Requirements:
B.S. / B. A. or 2 or more years experience
Experience:
1 or more years experience in the pharmaceutical industry including a working knowledge of GMPs

Knowledge/Skills Requirements:
Organizational Skills
Communication Skills- Oral & Written
Excellent Time Management Skills
Multi-tasking
Access Database Management
Word Processing
Compliance Wire (preferred)
EOE/ADA



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